Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction

REVIVED-BCIS2 Investigators; Divaka Perera; Tim Clayton; Peter D O'Kane; John P Greenwood; Roshan Weerackody; Matthew Ryan; Holly P Morgan; Matthew Dodd; Richard Evans; Ruth Canter; Sophie Arnold; Lana J Dixon; Richard J Edwards; Kalpa De Silva; James C Spratt; Dwayne Conway; James Cotton; Margaret McEntegart; Amedeo Chiribiri; Pedro Saramago; Anthony Gershlick; Ajay M Shah; Andrew L Clark; Mark C Petrie

doi:10.1056/NEJMoa2206606

Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction

REVIVED-BCIS2 Investigators, Divaka Perera, Tim Clayton, Peter D O'Kane, John P Greenwood, Roshan Weerackody, Matthew Ryan, Holly P Morgan, Matthew Dodd, Richard Evans, Ruth Canter, Sophie Arnold, Lana J Dixon, Richard J Edwards, Kalpa De Silva, James C Spratt, Dwayne Conway, James Cotton, Margaret McEntegart, Amedeo ChiribiriPedro Saramago, Anthony Gershlick, Ajay M Shah, Andrew L Clark, Mark C Petrie

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Abstract

BACKGROUND Whether revascularization by percutaneous coronary intervention (PCI) can improve event-free survival and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown. METHODS We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores. RESULTS A total of 700 patients underwent randomization - 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P = 0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, -1.6 percentage points; 95% CI, -3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, -1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months. CONCLUSIONS Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure.

Original language	English
Pages (from-to)	1351-1360
Number of pages	10
Journal	New England Journal of Medicine
Volume	387
Issue number	15
Early online date	27 Aug 2022
DOIs	https://doi.org/10.1056/NEJMoa2206606
Publication status	Published - 13 Oct 2022

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10.1056/NEJMoa2206606

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REVIVED-BCIS2 Investigators, Perera, D., Clayton, T., O'Kane, P. D., Greenwood, J. P., Weerackody, R., Ryan, M., Morgan, H. P., Dodd, M., Evans, R., Canter, R., Arnold, S., Dixon, L. J., Edwards, R. J., De Silva, K., Spratt, J. C., Conway, D., Cotton, J., McEntegart, M., ... Petrie, M. C. (2022). Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. New England Journal of Medicine, 387(15), 1351-1360. https://doi.org/10.1056/NEJMoa2206606

@article{2cb90b05cc36403bb981799de5f814c2,

title = "Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction",

abstract = "BACKGROUND Whether revascularization by percutaneous coronary intervention (PCI) can improve event-free survival and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown. METHODS We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores. RESULTS A total of 700 patients underwent randomization - 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P = 0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, -1.6 percentage points; 95% CI, -3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, -1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months. CONCLUSIONS Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure.",

author = "{REVIVED-BCIS2 Investigators} and Divaka Perera and Tim Clayton and O'Kane, {Peter D} and Greenwood, {John P} and Roshan Weerackody and Matthew Ryan and Morgan, {Holly P} and Matthew Dodd and Richard Evans and Ruth Canter and Sophie Arnold and Dixon, {Lana J} and Edwards, {Richard J} and {De Silva}, Kalpa and Spratt, {James C} and Dwayne Conway and James Cotton and Margaret McEntegart and Amedeo Chiribiri and Pedro Saramago and Anthony Gershlick and Shah, {Ajay M} and Clark, {Andrew L} and Petrie, {Mark C}",

note = "Funding Information: Supported by the NIHR Health Technology Assessment Program (award 10/57/67). Funding Information: The trial design has been described previously. REVIVED was a prospective, multicenter, randomized, open-label trial involving patients with ischemic left ventricular systolic dysfunction. The trial was funded by the National Institute for Health and Care Research Health Technology Assessment Program and sponsored by King{\textquoteright}s College London. The (available with the full text of this article at NEJM.org) was approved by the U.K. Health Research Authority, and all the patients provided written informed consent. An independent steering committee and a data and safety monitoring committee oversaw the trial. An independent clinical-events committee, the members of which were unaware of the trial-group assignments, adjudicated the key outcomes (see the , available at NEJM.org). The London School of Hygiene and Tropical Medicine Clinical Trials Unit coordinated the trial and performed the statistical analyses. The authors had access to the trial data and vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol. The initial draft of the manuscript was written by the first author. Publisher Copyright: Copyright {\textcopyright} 2022 Massachusetts Medical Society.",

year = "2022",

month = oct,

day = "13",

doi = "10.1056/NEJMoa2206606",

language = "English",

volume = "387",

pages = "1351--1360",

journal = "New England Journal of Medicine",

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REVIVED-BCIS2 Investigators, Perera, D, Clayton, T, O'Kane, PD, Greenwood, JP, Weerackody, R, Ryan, M , Morgan, HP, Dodd, M, Evans, R, Canter, R, Arnold, S, Dixon, LJ, Edwards, RJ , De Silva, K, Spratt, JC, Conway, D, Cotton, J, McEntegart, M, Chiribiri, A, Saramago, P, Gershlick, A, Shah, AM , Clark, AL & Petrie, MC 2022, 'Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction', New England Journal of Medicine, vol. 387, no. 15, pp. 1351-1360. https://doi.org/10.1056/NEJMoa2206606

TY - JOUR

T1 - Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction

AU - REVIVED-BCIS2 Investigators

AU - Perera, Divaka

AU - Clayton, Tim

AU - O'Kane, Peter D

AU - Greenwood, John P

AU - Weerackody, Roshan

AU - Ryan, Matthew

AU - Morgan, Holly P

AU - Dodd, Matthew

AU - Evans, Richard

AU - Canter, Ruth

AU - Arnold, Sophie

AU - Dixon, Lana J

AU - Edwards, Richard J

AU - De Silva, Kalpa

AU - Spratt, James C

AU - Conway, Dwayne

AU - Cotton, James

AU - McEntegart, Margaret

AU - Chiribiri, Amedeo

AU - Saramago, Pedro

AU - Gershlick, Anthony

AU - Shah, Ajay M

AU - Clark, Andrew L

AU - Petrie, Mark C

N1 - Funding Information: Supported by the NIHR Health Technology Assessment Program (award 10/57/67). Funding Information: The trial design has been described previously. REVIVED was a prospective, multicenter, randomized, open-label trial involving patients with ischemic left ventricular systolic dysfunction. The trial was funded by the National Institute for Health and Care Research Health Technology Assessment Program and sponsored by King’s College London. The (available with the full text of this article at NEJM.org) was approved by the U.K. Health Research Authority, and all the patients provided written informed consent. An independent steering committee and a data and safety monitoring committee oversaw the trial. An independent clinical-events committee, the members of which were unaware of the trial-group assignments, adjudicated the key outcomes (see the , available at NEJM.org). The London School of Hygiene and Tropical Medicine Clinical Trials Unit coordinated the trial and performed the statistical analyses. The authors had access to the trial data and vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol. The initial draft of the manuscript was written by the first author. Publisher Copyright: Copyright © 2022 Massachusetts Medical Society.

PY - 2022/10/13

Y1 - 2022/10/13

N2 - BACKGROUND Whether revascularization by percutaneous coronary intervention (PCI) can improve event-free survival and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown. METHODS We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores. RESULTS A total of 700 patients underwent randomization - 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P = 0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, -1.6 percentage points; 95% CI, -3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, -1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months. CONCLUSIONS Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure.

AB - BACKGROUND Whether revascularization by percutaneous coronary intervention (PCI) can improve event-free survival and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown. METHODS We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores. RESULTS A total of 700 patients underwent randomization - 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P = 0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, -1.6 percentage points; 95% CI, -3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, -1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months. CONCLUSIONS Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure.

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U2 - 10.1056/NEJMoa2206606

DO - 10.1056/NEJMoa2206606

M3 - Article

C2 - 36027563

SN - 1533-4406

VL - 387

SP - 1351

EP - 1360

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 15

ER -

Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction

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